The present invention relates to an apparatus for collecting and isolating a fluid specimen, and more particularly to a cup which can be used to receive, transport and store a fluid specimen as well as to provide an isolated sample for a fluid characterization testing.
Many tests are conducted to characterize the component or detect certain components or compounds of interest in fluids from the environment or body fluids. For example, employers sometimes test urine samples of prospective employees to determine whether the individual abuses controlled substances such as illegal drugs. Generally, a fluid sample is collected in an open mouth jar, and then closed and transported to the testing location. Several types of devices have been designed to collect uncontaminated urine such as the devices disclosed in U.S. Pat. Nos. 4,040,791; 4,393,881: 4,557,274; 4,569,090 and 5,797,855.
After a sample is collected, it is important to maintain the integrity of the sample until the time of testing. Adulteration of the collected fluid should be prevented to ensure an accurate test result. To prevent adulteration after collection, the cup contents should be maintained in a securely sealed, uncontaminated state.
In the testing of a fluid sample, most collection cups require opening the collection cup lid and transferring a small amount of the sample for testing. Many fluids being tested such as body fluids are considered to be potentially infectious and should be handled with proper caution. The test operator and/or surroundings can be contaminated and infected during transfer by contact with or spilling the sample fluid. Furthermore, the collected fluid sample itself can be contaminated by the surroundings and thereby lose its integrity. When the sample is transferred and tested, the identity of the sample can be confused with others, resulting in an uncertain conclusion. Therefore, it would be desirable if the test can be performed without transferring the sample fluid from the original collection cup.
U.S. Pat. Nos. 3,980,436; 4,385,115; 4,827,944; 4,960,130; 5,016,644; 5,038,793; 5,077,012; 5,215,102; 5,283,038; 5,368,583 and 5,403,551 disclose the introduction of test strips or other test devices into a specimen collection device in a general sense. These devices permit the testing of a sample without requiring transfer of the sample out of the collection device. However, some of these devices present problems with mechanism for communicating the sample to the test strips or they cannot ensure that at least a portion of the original sample remains isolated from the initial testing, since the test strip or test device is not isolated from the main body of collected fluid and consequently contamination from the test device is not eliminated.
It is highly desirable that the integrity of a fluid sample be maintained for later use of the sample, especially in the case of testing of urine for the presence of drugs. The collected urine sample must generally be kept until a confirmation test is later performed.
U.S. Pat. Nos. 4,976,923; 5,119,830 and 5,591,401 disclose in general terms urine collection cups that have a test strip on the lid. In these devices, it is typically necessary to invert the cup in order for the sample to be contacted with the test strip and spilling of the sample fluid can occur if the lid is not tightly closed. The collection cup in U.S. Pat. No. 5,976,895 can be used to collect and test urine in the same cup. However, the specimen is not divided into two portions prior to testing and contamination of the specimen from, for example, the test strip can occur.
Thus, there is a need for a fluid collection cup that is easy to use and prevents contamination from both laboratory technician and collected fluid by preventing contact of one with the other. Second, there is a need for a fluid collection cup that can be transported without spilling the sample and that is protected from tampering after collection. Third, there is a need for a fluid collection cup that can preserve collected fluid in a secure, intact state until the time of a confirmation test.
These and other features and objects of the invention will be more fully understood from the following detailed description of the preferred embodiments which should be read in light of the accompanying drawings.